RNA vaccines

Certara’s Vaccine Simulator™ Accurately Predicted Optimal Timing Between Doses for COVID-19

Retrieved on: 
Friday, July 23, 2021

PRINCETON, N.J., July 23, 2021 (GLOBE NEWSWIRE) -- Certara, a global leader in biosimulation, today announced that its Vaccine Simulator accurately predicted that eight weeks was the optimal timing between the first and second dose of COVID-19 vaccines.

Key Points: 
  • PRINCETON, N.J., July 23, 2021 (GLOBE NEWSWIRE) -- Certara, a global leader in biosimulation, today announced that its Vaccine Simulator accurately predicted that eight weeks was the optimal timing between the first and second dose of COVID-19 vaccines.
  • The Pitch study conducted at Oxford University in the United Kingdom confirmed Certaras Vaccine Simulator prediction, which was released six months ago .
  • Current dosing for the Pfizer-BioNTech and Moderna vaccines are spaced three and four weeks apart, respectively.
  • We have recently calibrated and validated our Vaccine Simulator with very large clinical data sets and added additional vaccine types, said Piet van der Graaf, PharmD, PhD, senior vice president of QSP at Certara.

EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for the Use of the Moderna COVID-19 Vaccine in Adolescents (12-17 Years of Age) in the European Union

Retrieved on: 
Friday, July 23, 2021

Spikevax is the trade name authorized by the European Medicines Agency (EMA) for the Moderna COVID-19 vaccine.

Key Points: 
  • Spikevax is the trade name authorized by the European Medicines Agency (EMA) for the Moderna COVID-19 vaccine.
  • Following the CHMPs positive opinion, the European Commission will consider authorizing the use of the Moderna COVID-19 Vaccine in adolescents ages 12 years of age and older.
  • The study met its primary endpoint, successfully bridging immune responses to those observed in the COVE efficacy study in adults.
  • The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein.

Pfizer And BioNTech to Supply U.S. Government with an Additional 200 Million Doses of COVID-19 Vaccine to Help Meet Continued Need for Vaccine Supply in the U.S.

Retrieved on: 
Friday, July 23, 2021

This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million.

Key Points: 
  • This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million.
  • These additional doses will help the U.S. government ensure broad vaccine access into next year.
  • The companies expect to deliver 110 million of the additional doses by December 31, 2021, with the remaining 90 million doses to be delivered no later than April 30, 2022.
  • The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

Pfizer and BioNTech to Provide U.S. Government with an Additional 200 Million Doses of COVID-19 Vaccine to Help Meet Continued Need for Vaccine Supply in the U.S.

Retrieved on: 
Friday, July 23, 2021

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine.
  • This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million.
  • These additional doses will help the U.S. government ensure broad vaccine access into next year.
  • The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

Vaxzevria® Brand Naming Strategy and Logo Revealed

Retrieved on: 
Thursday, July 22, 2021

MIAMI, July 22, 2021 /PRNewswire/ -- Brand Institute , the global leader in pharmaceutical and healthcare-related name development, is proud to share the official logo and creative naming strategy for AstraZeneca's COVID-19 vaccine: Vaxzevria (vax zev' ree ah).

Key Points: 
  • MIAMI, July 22, 2021 /PRNewswire/ -- Brand Institute , the global leader in pharmaceutical and healthcare-related name development, is proud to share the official logo and creative naming strategy for AstraZeneca's COVID-19 vaccine: Vaxzevria (vax zev' ree ah).
  • The name, which was developed by Brand Institute, was first announced by the European Medicines Agency (EMA) on March 25, 2021.
  • "When AstraZeneca approached Brand Institute about partnering on the name for their COVID-19 vaccine, their goals were clear," said Brand Institute's Chairman and CEO, James L. Dettore.
  • The logo for Vaxzevria further underscores the intended messaging of the brand name, with its bold font and brilliant icon, paying homage to AstraZeneca's corporate logo and evoking the interconnected nature of the human race.

Moderna Announces New Supply Agreement with Taiwan for 20 Million Doses of Moderna’s COVID-19 Vaccine and Variant Booster Vaccine Candidate in 2022 and 15 Million Doses in 2023

Retrieved on: 
Thursday, July 22, 2021

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a new supply agreement with Taiwan for 20 million doses of Modernas COVID-19 vaccine and its updated variant booster vaccine candidate, if authorized, to begin delivery in 2022 and an additional 15 million doses in 2023.

Key Points: 
  • Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a new supply agreement with Taiwan for 20 million doses of Modernas COVID-19 vaccine and its updated variant booster vaccine candidate, if authorized, to begin delivery in 2022 and an additional 15 million doses in 2023.
  • This new supply agreement is in addition to the prior agreement for 5 million doses in 2021.
  • We thank Taiwan for their support in securing this new agreement to supply in 2022 and 2023 our mRNA COVID-19 vaccine and our updated variant booster candidate, if approved, said Stphane Bancel, Modernas Chief Executive Officer.
  • We remain committed to making our vaccine available around the world.

Oramed Provides Update on Oravax: Oral Vaccine Maker Gets IRB Approval for Clinical Trial

Retrieved on: 
Wednesday, July 21, 2021

Oravax is gearing up to commence clinical trials for its oral COVID-19 vaccine, first in Israel, then in additional clinical sites internationally.

Key Points: 
  • Oravax is gearing up to commence clinical trials for its oral COVID-19 vaccine, first in Israel, then in additional clinical sites internationally.
  • The oral VLP COVID-19 vaccine is being developed for use both as a standalone vaccine as well as a booster for people who have been previously vaccinated for COVID-19.
  • Oravax combines cutting-edge vaccine technology acquired from Premas Biotech and the proprietary POD oral delivery technology of Oramed Pharmaceuticals.
  • Established in 2006, with offices inthe United StatesandIsrael, Oramed has developed a novel Protein Oral Delivery (POD) technology.

Catalent Plans Multi-Phase, $100 Million Expansion of Italian Facility to Increase Biologics Manufacturing Capabilities in Europe

Retrieved on: 
Wednesday, July 21, 2021

SOMERSET, N.J., July 21, 2021 /PRNewswire-PRWeb/ -- Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it will commence the first phase of a planned $100 million expansion program at its facility in Anagni, Italy, to add biologics drug substance manufacturing capabilities, supporting the growing European market demand for biologics manufacture and supply.

Key Points: 
  • The initial expansion is expected to be commissioned and operational for customer projects in April 2023 and will increase the site's workforce by up to 100 employees.
  • Later phases of the planned expansion contemplate the provision of 16,000 liters of total flexible manufacturing capacity, enabling 2,000-liter to 8,000-liter batch production scale.
  • Catalent's Anagni site is a world-class biologics and oral dose manufacturing facility that specializes in late-stage and commercial product launches.
  • Since Catalent acquired the facility, in January 2020, it has become a major European hub for COVID-19 vaccine manufacturing.

Free Digital COVID-19 Vaccine Card Service Now Available for Talbot County Residents

Retrieved on: 
Tuesday, July 20, 2021

EASTON, Md., July 20, 2021 /PRNewswire/ -- TalbotCounty Health Department and PinPoint US, LLC are partnering to offer free digital COVID-19 vaccine cards forTalbotCounty residents.

Key Points: 
  • EASTON, Md., July 20, 2021 /PRNewswire/ -- TalbotCounty Health Department and PinPoint US, LLC are partnering to offer free digital COVID-19 vaccine cards forTalbotCounty residents.
  • TheVaccineCheckservice will generate a personalized digital version of a CDC vaccine card after verifying COVID-19 vaccine history through Maryland's statewide immunization registry.
  • Residents can also use the service to upload images of their paper CDC vaccine card for safe digital record-keeping accessible through their smartphone or computer.
  • Many residents live and work in different jurisdictions, so we are pleased to offer this vaccine verification service across state and county lines," says Chris Nickerson, VaccineCheck Managing Partner.

Moderna Partners with Takeda and the Government of Japan to Supply Additional 50 Million Doses of Moderna’s COVID-19 Vaccine and Variant Booster Vaccine Candidate in 2022

Retrieved on: 
Tuesday, July 20, 2021

This new supply agreement is in addition to the prior agreement for 50 million doses in 2021 resulting in a total of 100 million doses for Japan.

Key Points: 
  • This new supply agreement is in addition to the prior agreement for 50 million doses in 2021 resulting in a total of 100 million doses for Japan.
  • Moderna is responsible for the manufacture and supply of Modernas vaccine candidate, and Takeda, with the support of the MHLW and Moderna, is responsible for all import, local regulatory, development and distribution activities in Japan for these additional 50 million doses beginning in 2022.
  • We thank the MHLW and Takeda for their support and for partnering with us to bring our mRNA COVID-19 vaccine to Japan, said Stphane Bancel, Modernas Chief Executive Officer.
  • We remain committed to making our vaccine available around the world as we seek to address the pandemic.